Clinical trial • Phase II • Dermatology|Immunology
Aldesleukin for Primary sclerosing cholangitis | Mucous membrane pemphigoid | Polymyositis/dermatomyositis | Pemphigus vulgaris/foliaceus
Phase II trial of Aldesleukin for Primary sclerosing cholangitis | Mucous membrane pemphigoid | Polymyositis/dermatomyositis | Pemphigus vulgaris/foliaceu…
Overview
- Trial Therapeutic Area
- Dermatology|Immunology
- Trial Disease
- Primary sclerosing cholangitis | Mucous membrane pemphigoid | Polymyositis/dermatomyositis | Pemphigus vulgaris/foliaceus
- Trial Stage
- Phase II
- Drug Modality
- Peptide/protein/enzyme|Small molecule
- Orphan Drug
- Yes
Key dates
- Initial CTIS Submission Date
- 26-01-2024
- First CTIS Authorization Date
- 04-04-2024
Trial design
Randomised, placebo (glucose 5%) — subcutaneous placebo administered matching the aldesleukin schedule: daily subcutaneous injections for five consecutive days (induction) followed by seven weekly subcutaneous injections until end-of-treatment at day 57 (+/-1).-controlled Phase II trial across 1 site in Germany.
- Randomised
- Yes
- Comparator
- Placebo (Glucose 5%) — subcutaneous placebo administered matching the aldesleukin schedule: daily subcutaneous injections for five consecutive days (induction) followed by seven weekly subcutaneous injections until End-of-Treatment at day 57 (+/-1).
- Target Sample Size
- 112
- Trial Duration For Participant
- 57
Eligibility
Recruits 112 Vulnerable population selected (isVulnerablePopulationSelected = true). Subject information and informed consent forms are listed among trial documents (e.g. L1_SIS and ICF_Main Study_GER_Redacted; L2_SIS and ICF_Accessory Biological Sampling_GER_Redacted; L3_SIS and ICF_Skin Biopsy_GER; L4_Information Leaflet_GER). No specific consent/assent handling details or age-specific consent procedures are provided in the available CTIS metadata..
- Vulnerable Population
- Vulnerable population selected (isVulnerablePopulationSelected = true). Subject information and informed consent forms are listed among trial documents (e.g. L1_SIS and ICF_Main Study_GER_Redacted; L2_SIS and ICF_Accessory Biological Sampling_GER_Redacted; L3_SIS and ICF_Skin Biopsy_GER; L4_Information Leaflet_GER). No specific consent/assent handling details or age-specific consent procedures are provided in the available CTIS metadata.
Inclusion criteria
- {"criterion_text":"- Participants with pemphigus vulgaris / foliaceus (PV/PF) and having mild to moderate disease activity as defined by a PDAI ≥ 6 and ≤ 45."}
- {"criterion_text":"- Participants with mucous membrane pemphigoid (MMP) and having mild to moderate disease activity as defined by a MMPDAI of ≥ 6 and ≤ 45."}
- {"criterion_text":"- Participants with polymyositis (PM) or dermatomyositis (DM) and having elevated plasma concentrations of the creatine kinase (CK) of ≥ 300 U/L and ≤ 3000 U/L. Concomitant diagnoses of other rheumatic diseases (overlaps) are allowed."}
- {"criterion_text":"- Participants with primary sclerosing cholangitis (PSC) and having elevated plasma concentrations of the alkaline phosphatase (AP) of ≥ 1.5 times above the upper limit of normal. Concomitant diagnosis of inflammatory bowel diseases is allowed."}
- {"criterion_text":"- Age of participants: ≥ 18 years and ≤ 80 years."}
Exclusion criteria
- {"criterion_text":"- Severe impairment of vital organ or life-threatening disease"}
- {"criterion_text":"- Chronically active infectious diseases"}
Endpoints
Primary endpoints
- {"endpoint_text":"- The IL-2 induced Treg response, defined as the increase in absolute numbers of CD3+CD4+FoxP3+CD127loCD25hi Treg according to the area under the curve (AUC) obtained between day 1 and day 57,","definition_or_measurement_approach":"Defined as increase in absolute numbers of CD3+CD4+FoxP3+CD127loCD25hi Treg; measured as area under the curve (AUC) between day 1 and day 57."}
- {"endpoint_text":"- The clinical response at day 57 assessed by absolute changes in disease-specific and z-standardized disease activity measures from day 1 to day 57. The respective disease activity measures for each of the investigated diseases are the Pemphigus Disease Area Index (PDAI), Mucous Membrane Pemphigoid Disease Area Index (MMPDAI), plasma levels of Creatine-Kinase (CK) or Alkaline Phosphatase (AP).","definition_or_measurement_approach":"Clinical response at day 57 measured by absolute changes in disease-specific and z-standardized measures from day 1 to day 57. Disease-specific measures: PDAI (pemphigus), MMPDAI (mucous membrane pemphigoid), plasma CK (polymyositis/dermatomyositis), plasma AP (PSC)."}
Secondary endpoints
- {"endpoint_text":"- The clinical response at day 57, assessed by absolute and relative changes in disease-specific measures (PDAI, MMPDAI, CK, AP) between day 1 and day 57 compared with placebo.","definition_or_measurement_approach":"Assessed by absolute and relative changes in disease-specific measures (PDAI, MMPDAI, CK, AP) from day 1 to day 57 compared with placebo-treated participants."}
Recruitment
- Planned Sample Size
- 112
- Recruitment Window Months
- 36
- Consent Approach
- Informed consent documents are included among published trial documents (e.g. L1_SIS and ICF_Main Study_GER_Redacted; L2_SIS and ICF_Accessory Biological Sampling_GER_Redacted; L3_SIS and ICF_Skin Biopsy_GER; L4_Information Leaflet_GER). Participants are adults (≥18 years) and provide informed consent. Documents available in German (document titles indicate German language). No details on assent or multi-language consent forms are provided in the CTIS metadata.
Geography
- Total Number Of Sites
- 1
- Total Number Of Participants
- 112
Germany
- Earliest CTIS Part Ii Submission Date
- 12-03-2024
- Latest Decision Or Authorization Date
- 15-01-2025
- Processing Time Days
- 309
- Number Of Sites
- 1
- Number Of Participants
- 112
Sites
- Site Name
- Universitaetsklinikum Schleswig-Holstein AöR
- Department Name
- Rheumatology and Clinical Immunology
- Principal Investigator Name
- Jens Humrich
- Principal Investigator Email
- jens.humrich@uksh.de
- Contact Person Name
- Jens Humrich
- Contact Person Email
- jens.humrich@uksh.de
- Number Of Participants
- 112
Sponsor
Primary sponsor
- Full Name
- Universitaetsklinikum Schleswig-Holstein AöR
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- Germany
Third parties
- {"country":"","full_name":"Deutsche Forschungsgemeinschaft (DFG)","duties_or_roles":"Source of monetary support","organisation_type":""}
Investigational products
- Investigational Product Name
- PROLEUKIN® S 18 x 106 IE Pulver zur Herstellung einer Injektionslösung oder Infusionslösung
- Active Substance
- Aldesleukin
- Modality
- Peptide/protein/enzyme
- Routes Of Administration
- Subcutaneous
- Route
- Subcutaneous
- Authorisation Status
- Marketing authorisation exists (marketingAuthNumber: 17152.00.00)
- Orphan Designation
- Yes
- Starting Dose
- 1.5 million IU (1,500,000 IU) subcutaneously (induction schedule)
- Dose Levels
- 1.5 million IU (single dose level used in study)
- Frequency
- Daily for five consecutive days (induction), followed by seven weekly injections (maintenance) until day 57 (+/-1)
- Maximum Dose
- Max daily dose 1,500,000 IU; max total dose amount 18,000,000 IU
- Investigational Product Name
- GLUCOSE (placebo)
- Active Substance
- Glucose
- Modality
- Small molecule
- Routes Of Administration
- Subcutaneous
- Route
- Subcutaneous
- Authorisation Status
- No marketing authorisation (marketingAuthNumber: -)
- Starting Dose
- Placebo administered matching aldesleukin schedule; maximum daily volume up to 10 ml as per product data
- Frequency
- Matched to aldesleukin: daily for five days then weekly for seven weeks until day 57
- Maximum Dose
- Max daily volume 10 ml (per product entry)
Related trials
Other published trials that may interest you.